System for orthopedic implantation preparation

ABSTRACT

A system for preparing a bone for implantation of a component of an orthopedic implant device. The system includes a forming tool having a sleeve member that is selectively received within a handle member. The sleeve member has a guide slot that is sized to receive axial passage of at least a portion of a guide. The guide slot and/or sleeve member may be positioned and/or configured to facilitate at least linear and/or rotational displacement of the forming tool about, or relative to, the guide, and thereby provide a degree of freedom in the location at which the forming tool may form a shape or opening in the bone relative to one or more reference axes. The handle member may include a connection member that is structured to be operably coupled to a bone preparation device that is structured to facilitate the displacement of bone material.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 15/572,967 filed Nov. 9, 2017, which is a U.S. National Phaseof International PCT Application No. PCT/US2016/032399 filed May 13,2016, which claims the benefit of U.S. Provisional Application Ser. No.62/161,031 filed May 13, 2015, the contents of each applicationincorporated herein by reference in their entirety.

BACKGROUND

Embodiments of the present application generally relate to preparatoryinstrumentation for implantation of an orthopedic implant or componentin a bone. More particularly, but not exclusively, embodiments of thepresent application relate to instrumentation for implantation of ametaphyseal and/or diaphyseal implant or augment relative to, and withselectively limited freedom about, one or more reference axis(es).

Proper alignment of a replacement joint device, including components ofthe replacement joint device, often can contribute to attaining optimalwear resistance performance of the implanted device. Yet, anatomicalvariations present challenges in properly aligning the implant devicefor each patient. For example, during implant construct of kneereplacement joints, challenges can arise with fitting a patient'sintramedullary geometry with an implant, such as, for example, anintramedullary stem, while also fitting both the external geometry witha condylar replacing implant and the metaphyseal and/or diaphysealgeometry with an associated implant or augment component. Moreover, theaddition of a metaphyseal and/or diaphyseal implant or augment to animplant construct often impairs the ability to adjustably fit theimplant to the patient and/or attain proper alignment of the variouscomponents of the implant. Such difficulties can at times be attributedto the anatomy of the patient, the geometrical constraints of theimplant, and/or constraints associated with the preparatoryinstrumentation. For example, geometrical constraints of the metaphysealand/or diaphyseal implant or augment can include the inability toaccommodate the placement or position of both the intramedullary stemand the condylar implant, which can attribute to difficulties in forminga junction mechanism for those, and possibly other, components of theimplant.

Challenges associated with attaining proper alignment during implantconstruct that involves a metaphyseal and/or diaphyseal implant oraugment may have, at times, been resolved by compromises in terms of theplacement of at least some components of the implant device, such as,for example, the location of the condylar implant. Yet, such compromisescan result in less than optimal hone coverage, which can potentiallycompromise loading of the construct to the cortical rim of the bone.Other compromises can include reducing the stem size in order to offsetthe stem position, with the area vacated by such offsetting being madeup with cement. Yet, such compromises can adversely impact the life ofthe implant, and can be, at least in part, attributable to failuresrelating to subsidence, loosening, stress-shielding factors, andincreased stresses on the implant device, among other failures that areassociated with compromised articulation positioning.

The integrity of the implant construct can therefore be adverselyimpacted if the bone is not shaped, during implant surgery, toaccommodate the positioning of augmenting implants at locations in whichthe implanted augments, such as, for example, stems, sleeves, and cones,among other augments, will not interfere with the articular componentand/or other augmenting implants. Yet, the different anatomies ofpatients often present challenges in the ability to position augmentingimplants at optimal locations. For example, in order to achieve optimalbone coverage, the articular component stem connection (post) axis canneed to be at a location that is different than the stem axis. Further,the inability to attain such positioning can lead to compromises in thestructure, life span, and/or performance of the implanted device, amongother compromises.

BRIEF SUMMARY

An aspect of the present application is an apparatus for use with a bonepreparation device, the apparatus having a sleeve member that has aguide slot that is sized to receive axial passage of at least a portionof a guide. The guide slot is sized so accommodate linear displacementof the sleeve member about the received guide in one or more directionsthat are perpendicular to a longitudinal guide axis of the guide. Theapparatus also includes a handle member that has an inner area that issized to receive insertion of at least a portion of the sleeve member,the handle member having a connection member structured to be coupled tothe bone preparation device. The apparatus further includes a retentionmember that is adapted to selectively secure the sleeve member to thehandle member at a selected one of a plurality of rotational positions,each of the plurality of rotational positions adjusting an angularposition of at least the sleeve member relative to the handle member.

Another aspect of the present application is an apparatus for use with abone preparation device, the apparatus including a sleeve member thathas a guide slot that is sized to receive axial passage of at least aportion of a guide. Additionally, the guide slot has a central guideslot axis that is offset from a longitudinal sleeve axis of the sleevemember. The apparatus also includes a handle member that has an innerarea that is sized to receive removable insertion of at least a portionof the sleeve member. The handle member also has a connection memberthat is structured to be coupled to the bone preparation device. Theapparatus further includes a resection member that is adapted toselectively secure the sleeve member to the handle member at a selectedone of a plurality of rotational positions, each of the plurality ofrotational positions adjusting an angular position of at least the guideslot relative to a longitudinal handle axis of the handle member.

Another aspect of the present application is a bone preparation devicethat has a sidewall that extends about a central cutting axis of thebone preparation device. The sidewall has an outer surface an innersurface, the outer surface being structured to facilitate displacementof bone material, and the inner surface defining an aperture in the bonepreparation device. The bone preparation device also includes an upperwall that is adjoined to the sidewall. The upper wall has an openingthat is in fluid communication with the aperture. The opening includes apair of opposing recesses that are structured to extend a portion of asize of a portion of the opening. The opening further includes a slotthat outwardly extends from one of the pair of opposing recesses.Additionally, the upper wall defines, in part, a cavity that is adjacentto an inner wall of the upper wall. The cavity is structured to extend asize of a portion of the aperture.

BRIEF DESCRIPTION OF THE DRAWINGS

The description herein makes reference to the accompanying figureswherein like reference numerals refer to like parts throughout theseveral views.

FIG. 1 illustrates a front perspective view of a forming tool forpreparing a bone for implantation of an augment or implant deviceaccording to an illustrated embodiment of the present application.

FIG. 2 illustrates a front perspective view of an orientationreferencing instrument or guide that extends along a longitudinal guideaxis and which is inserted into an intramedullary canal of a patient.

FIG. 3 illustrates a front perspective view of at least a portion of theguide shown in FIG. 2 being positioned within at least a portion of theforming tool depicted in FIG. 1.

FIG. 4 illustrates a side perspective view of the forming tool shown inFIG. 1, without a bone preparation device, according to an illustratedembodiment of the present application.

FIG. 5 illustrates a side perspective view of a sleeve member for aforming tool having as elongated guide slot according to an illustratedembodiment of the present application.

FIG. 6 illustrates a side perspective view of a sleeve member for aforming tool having an offset guide slot according to an illustratedembodiment of the present application.

FIGS. 7A-C illustrate top views of an exemplary forming tool in which aguide is positioned at various locations within an elongated guide slotof a sleeve member.

FIGS. 8A-C illustrate examples of top views of a forming tool in which aguide is positioned within guide slots having various linear offsetdistances and in which the sleeve member is positioned relative to ahandle member to adjust an angular position of at least the forming toolrelative to the guide.

FIG. 9 illustrates a top perspective view of a portion of a forming toolin which a sleeve member having an elongated guide slot is beingpositioned relative to a handle member of the forming tool according toan illustrated embodiment of the present application.

FIG. 10 illustrates a top perspective view of a portion of a formingtool in which a sleeve member having an elongated guide slot is securedto a handle member according to an illustrated embodiment of the presentapplication.

FIG. 11 illustrates a top perspective view of a portion of a formingtool in which a sleeve member having an offset guide slot is beingpositioned relative to a handle member of the forming tool according toan illustrated embodiment of the present application.

FIG. 12 illustrates a top perspective view of a portion of a formingtool in which a sleeve member having an offset guide slot is secured toa handle member according to an illustrated embodiment of the presentapplication.

FIG. 13 illustrates a top perspective view of a portion of a handlemember of a forming tool according to an illustrated embodiment of thepresent application.

FIG. 14 illustrates a bottom perspective view of a sleeve member beinginserted into a guide member according to an illustrated embodiment ofthe present application.

FIG. 15 illustrates a connection member of a forming tool with anadjustable slide in a first, lock position, and an example of a bonepreparation device according to an illustrated embodiment of the presentapplication.

FIG. 16 illustrates an exemplary bone preparation device and anadjustable slide of a connection member being axially displaced to asecond, unlocked position according to an illustrated embodiment of thepresent application.

FIG. 17 illustrates a perspective view of the cutting assembly and thebone preparation device in FIG. 16 with the adjustable slide beingaxially displaced to the first, locked position and the forming toolbeing rotatably displaced relative to the bone preparation device to alocked position according to an illustrated embodiment of the presentapplication.

FIG. 18 illustrates a top perspective view of an example of a bonepreparation device according to an illustrated embodiment of the presentapplication.

FIG. 19 illustrates a front view of an exemplary tibial implant having atibial tray, a tibial augment, and a stem.

FIGS. 20A-20C illustrate exemplary uses of a forming tool having anelongated guide slot according to certain embodiments of the presentapplication to alter the location of the central augment axis, and thusthe location of the tibial augment in a bone, relative to at least astem and/or a tibial tray of a tibial implant.

FIGS. 21A-21C illustrate exemplary uses of a forming tool having anoffset guide slot according to certain embodiments of the presentapplication to alter the location of the central augment axis, and thusthe location of the tibial augment in a bone, relative to at least astem and/or a tibial tray of a tibial implant.

The foregoing summary, as well as the following detailed description ofcertain embodiments of the present application, will be betterunderstood when read in conjunction with the appended drawings in whichlike reference numbers indicate like features, components and methodsteps. For the purpose of illustrating the invention, there is shown inthe drawings, certain embodiments. It should be understood, however,that the present invention is not limited to the arrangements andinstrumentalities shown in the attached drawings.

DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

Certain terminology is used in the foregoing description for convenienceand is not intended to be limiting. Words such as “upper,” “lower,”“top,” “bottom,” “first,” and “second” designate directions in thedrawings to which reference is made. This terminology includes the wordsspecifically noted above, derivatives thereof, and words of similarimport. Additionally, the words “a” and “one” are defined as includingone or more of the referenced item unless specifically noted. The phrase“at least one of” followed by a list of two or more items, such as “A, Bor C,” means any individual one of A, B or C, as well as any combinationthereof.

FIG. 1 illustrates a front perspective view of a forming tool 100 forpreparing a bone for implantation of an augment or other implantcomponent (collectively referred to as “augment”) according to anillustrated embodiment of the present application. The forming tool 100includes a bone preparation device 102 that is selectively coupled to adistal end 104 of the forming tool 100, as discussed below. As alsodiscussed below in more detail, a proximal end 106 of the forming tool100 is adapted to at least assist in selectively adjusting the locationfor forming a cut in a bone using the bone preparation device 102 ateither, or both, a distance and direction away from one or morereference axis(es). The forming tool 100 is structured to receiveinsertion of, or otherwise engage, at least a portion of an orientationreferencing instrument or guide 108, such as, for example, aintramedullary rod, trial stem, reamer, or offset rod, among otherguides, as shown in FIGS. 2 and 3. According to the example provided inFIGS. 2 and 3, the guide 108 is an intramedullary rod that extends alonga longitudinal guide axis 110, which may, or may not, be aligned with alongitudinal reference axis of the intramedullary canal 113 in thepatient's bone 112. Further, according to the illustrated embodiment,the bone preparation device 102 is adapted to form an augment opening114 having a depth (as indicated by “X” in FIG. 2) in the bone 112.Further, the augment opening 114 is positioned about a central augmentaxis 116, as shown for example, in FIG. 2, and can be generally at thesame location, or can be angularly and/or linearly from one or moreaxes, a reference axis, such as, for example, the longitudinal guideaxis 110.

As shown by at least FIGS. 1 and 3-5, according to the illustratedembodiment, the forming tool 100 includes a sleeve member 118 and ahandle member 120. The sleeve member 118 includes a guide body 122 and aselector body 124. An outer wall 126 of the guide body 122 extendsbetween opposing first and second ends 128 a, 128 b of the guide body122, the first end 128 a being adjacent to the selector body 124. Theouter wall 126 of the guide body 122 can have a variety of shapes andsizes. For example, in the illustrated embodiment, at least a portion ofthe outer wall 126 has a generally elongated cylindrical shape thatextends along a longitudinal sleeve axis 130 of the sleeve member 118.The outer wall 126 can also form a hub portion 132 of the guide body 122that extends from a lower portion 134 of the selector body 124.

The guide body 122 includes a guide slot 136 that extends along at leasta portion of the outer wall 126, and which is sized to receive theinsertion of at least a portion of the guide 108. During operation ofthe forming tool 100 and/or the bone preparation device 102, the guide108 can be secured to the forming tool 100, such as, for example, viause of a retaining mechanism, including, but not limited to, a threaded,slotted, or spring capture retaining mechanism, among others.

The guide slot 136 can have a variety of different shapes and sizes. Forexample, as depicted in at least FIGS. 6 and 8A-8C, according to certainembodiments, the guide slot 136′ can have a generally cylindrical shape.However, according to other embodiments the guide slot 136 can have anelongated shape, as shown, for example, in at least FIGS. 5 and 7A-7C.Additionally, according to certain embodiments, the guide slot 136, 136′can extend along a centrally located guide slot axis 138 that isgenerally the same as, or aligned with, the longitudinal sleeve axis 130of the sleeve member 118. However, according to other embodiments, theguide slot axis 138 can be at least linearly offset, by varyingdistances, from the longitudinal sleeve axis 130 of the sleeve member118, the longitudinal guide axis 110, and/or another reference axis(es).For example, according to the embodiments illustrated in FIGS. 8A-8C,the sleeve members 118 a, 118 b, 118 c can be configured to provideguide slots 136′ that each have different linear offset distancesbetween the longitudinal sleeve 103 and the guide axis 110 and/or theguide axis slot 138, as indicated by offset distances D₁, D₂, and D₃,respectively. In the illustrated examples, linear offset distance D₁ isless than that of linear offset distance D₂, which is less than linearoffset distance D₃. Thus, according to certain embodiments, the formingtool 100 can be modular in that sleeve members 118 having guide slots136, 136′ of different shapes, sizes, and/or positioning of the guideslot axis 138 relative to the longitudinal sleeve axis 130, among otherreference axes, can be interchangeably selected for operable engagementwith the handle member 120, and thus for use with the forming, tool 100.

Referencing FIG. 5, according to certain embodiments, the guide slot 136can extend through a portion of the outer wall 126 so as to provide theguide slot 136 with a depth that extends from an opening 140 of theguide slot 136 to a bottom portion 142 of the guide slot 136. Accordingto such an embodiment, the bottom portion 142 of the guide slot 136 cancorrespond to a portion of the outer wall 126, with the bottom portion142 and the opening 140 of the guide slot 136 being generally atopposing sides or ends of the guide slot 136. Further, according to suchembodiments, the depth of the guide slot 136 can allow for adjustmentsin the location of at least the guide 108 within the guide slot 136, andthereby permit adjustments of the location of at least the guide 108relative to the guide slot axis 138 and/or the longitudinal sleeve axis130. Further, according to certain embodiments, one or more sleevemembers 118 can have guide slots 136 of different depths, therebyallowing for the selection of a guide body 122 that may, or may not,offset the guide 108 from at least the guide slot axis 138 by apredetermined or maximum distance.

Referencing FIGS. 7A-12, the selector body 124 of the sleeve member 118can include an aperture 144, 144′ that is in fluid communication withthe guide slot 136, 136′. According to certain embodiments, the aperture144, 144′ can have a shape that is generally similar to the shape, or isan extension, of the guide slot 136, 136′ such as, for example, having agenerally circular or elongated shape. However, the aperture 144, 144′of the selector body 124 can have a variety of other shapes. Forexample, according to the illustrated embodiment, the aperture 144, 144′can have a generally elongated shape, such as, for example, have alinear length (as indicated by “L” in FIG. 9) that is generally alignedwith or exceeds the size or depth of the guide slot 136, 136′ so as tofacilitate visual detection through the aperture 144, 144′ and/or theposition or location of the guide 108 in the guide slot 136, 136′.

An upper surface 146 of the selector body 124 can also include anindicator 148 that facilitates a determination of an angular orientationof at least the guide slot 136, 136′, guide slot axis 138, and/or theguide 108 relative to a reference axis, as discussed below. In theillustrated embodiment, the indicator 148 can include an indicium, suchas, for example, a word or symbol, including, but not limited to, anarrow. Further, according to certain embodiments, the indicium can bepositioned on an upper surface 146 of the selector body 124, such as,for example, in a groove 150 within the upper surface 146.

As shown by at least FIG. 13, the handle member 120 has an inner area152 that extends through the handle member 120, at least a portion ofthe inner area 152 being sized to receive insertion of at least theguide body 122 of the sleeve member 118. Further, a first end 154 a ofthe handle member 120 can be adapted for selective locking engagementwith the sleeve member 118. For example, according to the illustratedembodiment, the sleeve member 118 and the handle member 120 can beadapted for selectively releasable locking engagement that prevents bothaxial and rotational displacement of the sleeve member 118 relative tothe handle member 120. For example, the forming tool 100 can include alock member 156 that is adapted to retain the sleeve member 118 withinthe inner area 152 of the handle member 120 in a manner that can preventaxial displacement of the sleeve member 118 relative to the handlemember 120, while the selector body 124 of the sleeve member 118 isadapted for locking engagement with a selector hub 158 of the handlemember 120.

According to certain embodiments, the lock member 156 can be adapted tobe displaceable between a first, locked position and a second, unlockedposition. For example, according to certain embodiments, at least aportion of the lock member 156 can extend into at least the inner area152 of the handle member 120 when the lock member 156 is in the first,locked position. According to certain embodiments, when the guide body122 is inserted into the inner area 152 of the handle member 120, theguide body 122 can engage the lock member 156 in a manner that displacesthe lock member 156 from the first, locked position and to, and/ortoward, the second, unlocked position. According to such embodiment, asthe lock member 156 is displaced to and/or toward, the second, unlockedposition, at least a portion of the lock member 156 can be withdrawnfrom, or otherwise displaced within, the inner area 152. According toother embodiments, when the guide body 122 is to be inserted into theinner area 152, the user can exert a force against an outer selector orbutton 160 of the lock member 156 that displaces at least a portion ofthe lock member 156 in and/or from the inner area 152 so that the lockmember 156 does not prevent insertion of the guide body 122 into theinner area 152. Further, with the guide body 122 positioned in the innerarea 152, the lock member 156 can be displaced toward, or to, the first,locked position so that the lock member 156 is positioned to engaged theguide body 122 in a manner that prevents the axial displacement of thesleeve member 118 relative to the handle member 120. For example, aportion of lock member 156 can be received in a groove or recess in, orabove a portion of, the hub portion 132 of the guide body 122 so as toprevent the axial displacement of the sleeve member 118 relative to thehandle member 120. According to such embodiments, when the guide body122 is to be withdrawn from the inner area 152 of the handle member 120,the user can exert a force against the outer selector or button 160 ofthe lock member that displaces at least a portion of the lock member 156toward or to the second, unlocked position, so that the lock member 156is at a position that does not prevent the removal of the guide body 122from the inner area 152.

The handle member 120 can also be structured for selective, lockingengagement with a portion of the sleeve member 118 so as to secure atleast the angular position of the sleeve member 118 relative to thehandle member 120. For example, according to certain embodiments, aportion of the outer wall 126 of the sleeve member 118 and an inner wall162 of the handle member 120 can include portions of a retention member164 that can compromise, for example, one or more mating splines, keys,or teeth that facilitate selective, locking engagement in a manner thatpermits the positioning, and, if necessary, re-positioning of therotational position of the sleeve member 118 relative to the handlemember 120. According to certain embodiments, such mating splines can bepositioned at, or around, the selector hub 158 portion of the handlemember 120 and the selector body 124 of the guide body 122.

As illustrated in FIG. 14, according to other embodiments, the retentionmember 164 can be a pin that at least projects or extends at least fromthe lower portion 134 of the selector body 124 and is received in one ormore retention openings 166 along the handle member 120. A variety ofdifferent types of pins can be utilized for the projection member 164,including for example, a separate pin(s) that can be secured to theselector body 124 by a press fit, adhesive, or plastic weld, among othermanners of attachment. Alternatively, the pin(s) can be a unitary,monolithic portion or extension of the selector body 124. Further, thepin(s) can have a variety of different shapes and sizes, includinghaving generally circular or non-circular cross-sectional shape.Further, the shape and/or size of such a pin can be uniform ornon-uniform as the pin extends away from the selector body 124.Additionally, according to certain embodiments, at least a portion ofthe retention member 164 can be exposed or otherwise visible from orthrough the upper surface 146 of the selector body 124. For exampleaccording to certain embodiments, the retention member 164 can bepositioned in an aperture 168 that extends through the selector body124, thereby exposing at least an end of the retention member 164 at theupper surface 146 of the selector body 124. Such visual access to theretention member 164 from the upper surface 146 of the selector body 124can allow the retention member 164 to also provide another indication ofthe angular orientation of the guide slot 136, 136′ relative to thehandle member 120. Additionally, a visual indication of the angularlocation of the retention member 164 from the upper surface 146 of theselector body 124 can also facilitate positioning of the retentionmember 164 into locking engagement with a selected retention opening166.

Referencing FIGS. 9-13, an upper wall 170 at the first end 154 a of thehandle member 120 can include indicium that corresponds to one or moreof the retention openings 166. For example, in the illustratedembodiment, twelve retention openings 166 are positioned in a circularconfiguration about the upper wall 170 of the selector hub 158 andaround, or adjacent to the opening 172 to the inner area 152. Further,rotational position indicators 174 can correspond to the location of theretention openings 166, which are identified in the depicted embodimentby a line and a corresponding number, namely, numbers “1” through number“12”. However, a variety of other rotational positional indicators 174can be employed. The rotational position indicators 174 can provide anindication of the rotational position of at least the guide slot 136,136′ and/or guide slot axis 138 relative to reference axis, such as, forexample, the rotational position of the offset guide slot axis 138,and/or the longitudinal sleeve axis 130, among other reference axes.

The handle member 120 can also include a reference indicator 176 thatcan be structured for positioning and/or orientating at least the handlemember 120 relative to a reference point, location and/or direction,such as, for example, indicate a direction or orientation toward aparticular portion of the bone 112 or another instrument, among otherreference points. According to the illustrated embodiment, the referenceindicator 176 can extend away from the selector hub 158 of the handlemember 120. Further, an end 178 of the reference indicator 176 can beconfigured to improve the ease at which the reference indicator 176 ispositioned and/or orientated, or otherwise directed toward the referencepoint, location, and/or direction. For example, according to theillustrated embodiment, the reference indicator 176 can include a pairof opposing, converging end walls 180 a, 180 b that are joined togetherto generally form a point so as to provide the reference indicator 176with a pointed or arrow-shaped configuration. Moreover, the point at theend 178 can provide a generally centralized area that can improve theease at reference can be made to the reference point, location, and/ordirection when orienting the position or location of at least the handlemember 120.

The selector body 124 can also be shaped or configured to facilitate theability to grip or otherwise manipulate the position of the sleevemember 118, such as, for example, the angular position of the sleevemember 118 relative to the handle member 120. For example, according tothe illustrated embodiment, an outer edge 182 of the selector body 124can include a plurality or recesses 184 intermixed with a plurality ofprojections 186 that are structured to enhance the ability of a user tograsp, and/or retain a grasp of, the sleeve member 118. Such aconfiguration of the recesses 184 and projections 186 can also form aknurled surface along the outer edge 182.

A body portion 188 of the handle member 120 can extend between theselector hub 158 and a cutting assembly 190 of the handle member 120.According to the illustrated embodiment, the body portion 188 caninclude an outer wall 192 that has a generally cylindrical configurationthat extends along a longitudinal handle axis 194, as shown in FIG. 4.When the sleeve member 118 is positioned within the inner area 152 ofthe handle member 120, the longitudinal handle axis 194 and thelongitudinal sleeve axis 130 can at least be parallel and/or generallyaligned together. Additionally, the outer wall 192 along the bodyportion 188 can include a plurality of intermixed recesses 196 thatprovide protrusions 198 therebetween, which can improve the ease withwhich a user can securely grip and/or grasp the body portion 188.Additionally, similar to other portions of the handle member 120, theinner area 152 can extend through the body portion 188. Further,according to the illustrated embedment, the inner area 152 along thebody portion 188 can be sized to house at least a portion of the guidebody 122 of the sleeve member 118.

The cutting assembly 190 can include an adjustable slide 200 that isadapted for axial displacement between first and second slide positionsalong a portion of the outer wall 192 of the handle member 120.According to the illustrated embodiment, the adjustable slide 200 caninclude an outer slide wall 202 and an inner slide wall 204, the innerslide wall 204 extending around at least a portion of the outer wall 192of the handle member 120. The outer slide wall 202 can generally definean outer periphery of the adjustable slide 200. In the illustratedembodiment, the outer slide wall 202 extends along a hub portion 206 anda flange portion 208 of the adjustable slide 200. The adjustable slide200 can also include, or be coupled to an engagement member 210 that isconfigured to be received in a slot or groove 212 in the bonepreparation device 102. According to certain embodiments, the engagementmember 210 is a projection that extends from a lower surface or regionof the adjustable slide 200 and extends to, or around, a region of aconnection member 214 of the handle member 120, as discussed below.Further, the engagement member 210 and adjustable slide 200 can be partof a single, monolithic, or unitary construction. Alternatively, theengagement member 210 can be secured to the adjustable slide 200 by afastener 216, such as, for example, by a pin or screw, among otherfasteners.

According to certain embodiments, the adjustable slide 200 can besecured or biased in the first slide position, as illustrated forexample in FIGS. 15 and 17. For example, according to certainembodiments, the cutting assembly 190 can include a biasing element,such as, for example, a spring that biases the adjustable slide 200 tothe first slide position. Further, according to certain embodiments, theouter wall 192 of the handle member 120 and/or the inner slide wall 204of the adjustable slide 200 can include retention projections thatinterfere with the ability of the adjustable slide 200 to be displacedaway from the first slide position. Thus, when the adjustable slide 200is to be displaced to the second slide position, a force can be directedupon the adjustable slide 200 that overcomes the force provided by thebiasing element and/or retention projections, if any, so that theadjustable slide 200 can be displaced to the second position, as shownin FIG. 16. Alternatively, according to other embodiments, the fastener216 can be utilized to retain the adjustable slide 200 in the firstposition. Displacement of the adjustable slide 200 from the first slideposition to the second slide position can displace the engagement member210 to a position that does not interfere with at least the initialengagement of the bone preparation device 102 with the handle member120, as discussed below.

The handle member 120 can also include a static abutment 218 that can beposition to limit the extent the adjustable slide 200 can be axiallydisplaced away from the first slide position and/or control the locationof the second slide position. For example, the static abutment 218 canradially extend a distance away from at least a portion of the outerwall 192 of the handle member 120 such that the static abutment 218interferes with, or otherwise prevents, the passage of the adjustableslide 200 around or past the static abutment 218. According to theillustrated embodiment, the static abutment 218 can have a generallycylindrical shape. However, the static abutment 218 can have a varietyof other shapes and sizes. Additionally, according to certainembodiments, the flange portion 208 of the adjustable slide 200 can besized to engage or otherwise abut against the static abutment 218 in amanner that prevents the passage of the adjustable slide 200 past thestatic abutment 218. Further, according to certain embodiments, thestatic abutment 218 can also include a recess 220 that is adapted forconnection to an ancillary component of the forming tool 100, such as,for example, an alignment handle.

As shown in at least FIG. 4, according to certain embodiments, at leasta portion of the outer wall 192 around a second end 128 b of the handlemember 120 can include implantation indicia 222 relating to the positionand/or orientation of at least the bone preparation device 102 in thebone. For example, according to certain embodiments, the implantationindicia 222 can be a gauge that provides information relating to thedepth and/or angle at which the bone preparation device 102 has beeninserted into the bone. The implantation indicia 222 can be provided ina number of manners, including, for example, as shown in FIG. 4, asnumeric values and/or visual indicators, such as lines or othergraphical representations. More specifically, according to certainembodiments, the implantation indicia 222 can be a collection of numericvalues that increase in 5 millimeter (mm) increments.

Referencing FIGS. 4 and 15, the second end 128 b of the handle member120 includes a connection member 214 that is adapted to releasablysecure the bone preparation device 102 to the handle member 120. Avariety of different types of connection members 214 can be utilized,including, for example, a threaded connector that mates a threadedcomponent to the bone preparation device 102. According to theillustrated embodiment, the connection member 214 includes a pair ofarms 224 a, 224 b that extend from the distal end of the outer wall 192.The arms 224 a, 224 b can each include arm extensions 226 a, 226 b thateach outwardly protrude from a base portion 228 a, 228 b of the arms 224a, 224 b. Additionally, according to certain embodiments, at least aportion of the arms 224 a, 224 b, such as, for example, the base portion228 a, 228 b, can be structured to at least partially deform, bend, ordeflect at least when the arm extensions 226 a, 226 b are being insertedinto an aperture 230 of the bone preparation device 102. According tocertain embodiments, the aperture 230 of the bone preparation device 102can include an undercut 232 beneath an upper wall 234 of the bonepreparation device 102 that receives the insertion of at least a portionof the arm extensions 226 a, 226 b. According to such an embodiment,when the arm extensions 226 a, 226 b are positioned in the aperture 230of the bone preparation device 102, an upper surface 225 of the armextensions 226 a, 226 b can be at least positioned beneath at least aportion of the upper wall 234 of the bone preparation device 102. Suchpositioning of the arm extensions 226 a, 226 b beneath the upper wall234 of the bone preparation device 102 so as to at least assist inretaining a secure attachment or connection between the bone preparationdevice 102 and the handle member 120. Further, according to theillustrated embodiment, the arms 224 a, 224 b can be positioned alongthe second end 154 b of the handle member 120 at a location that ispositioned away, or radially offset from, the location of the engagementmember 210. For example, according to certain embodiments, theengagement member 210 can be positioned at, in opposite directions,about 90 degrees from each of the arms 224 a, 224 b. However, theengagement member can be located at a variety of other positionsrelative to the arms 224 a, 224 b.

FIG. 18 illustrates a bone preparation device 102 that is structure foroperable attachment to the connection member 214 of the forming tool 100according to an illustrated embodiment of the present application. Inthe depicted embodiment, the bone preparation device 102 is a broach.However, a variety of other types of bone preparation devices 102 can beused with the forming tool 100, including, for example, a reamer. In thedepicted embodiment, the bone preparation device 102 includes a sidewall231 having an outer surface 236 and an inner surface 244, the outersurface 236 being adapted to facilitate displacement of the bonepreparation device 102 into, and/or removal of, the surrounding bone112. Further, according to certain embodiments, the outer surface 236 ofthe bone preparation device 102 can symmetrically or asymmetrical extendabout a central cutting axis 238. According to the illustratedembodiment, during use, the central cutting axis 238 can be generallypositioned in general alignment with the longitudinal handle axis 194and/or the longitudinal sleeve axis 130. Moreover, in the illustratedembodiment, the longitudinal handle and sleeve axes 294, 130 can begenerally aligned with each other to provide a forming axis 240 for theforming tool 100, as shown in FIG. 1.

At least the aperture 230 of the bone preparation device 102 can beconfigured to facilitate a secure connection between the connectionmember 214 and the bone preparation device 102. According to theillustrated embodiment, the aperture 230 can be in fluid communicationwith an opening 233 of the upper wall 234 of the bone preparation device102, the opening 233 having one or more recesses 242 a, 242 b that aresized to receive placement of the arm extensions 226 a, 226 b into atleast the aperture 230. The extent to which the arm extensions 226 a,226 b can be axially displaced into the aperture 230 can also be limitedby an inner surface 244 of the aperture 230 and/or the length of thebase portion 228 a, 228 b of the arms 224 a, 224 b. Further, accordingto the illustrated embodiment, a slot 212 can extend outwardly from atleast one recess 242 a, 242 b in the upper wall 234. The slot 212 isconfigured to receive insertion of at least a portion of the engagementmember 210. Further, the engagement of the engagement member 210 withthe slot 212 can prevent rotational displacement of at least the handlemember 120 relative to the bone preparation device 102.

When the bone preparation device 102 is to be operably connected to theconnection member 214, the adjustable slide 200 can be displaced fromthe first slide position to the second slide position, as shown in FIG.16. With the adjustable slide 200 in the second slide position, theengagement member 210 can be displaced away from the connection memberby a distance that does not interfere with the arm extensions 226 a, 226b being inserted into a corresponding recess 242 a, 242 b. With the armextension 226 a, 226 b in the corresponding recess 242 a, 242 b, thebone preparation device 102 can be rotatably displaced relative to thehandle member 120, or vice versa, such that the extension arms 224 a,224 b enter into the undercut 232 portion of the aperture 230 beneath aninner wall 235 of the upper wall 234, as shown in FIGS. 17 and 18, andthereby prevents the bone preparation device 102 from being separatedfrom the connection member 214. Further, such rotation can position theengagement member 210 at a location that, when the adjustable slide 200is returned to the first slide position, at least a portion of theengagement member 210 is received in the slot 212 in the bonepreparation device 102 so as to prevent, during use of the forming tool100, rotational displacement of the bone preparation device 102 relativeto the handle member 120.

In the illustrated embodiment, the bone preparation device 102 is abroach. According to such an embodiment, during shaping or forming ofthe bone 112, an upper end of the forming tool 100 can be impacted by atool, such as, for example, a mallet, that forces the bone preparationdevice 102 into the bone 112. The forming tool 100 can continue to beimpacted by the tool until the bone preparation device 102 attains aparticular depth and/or a particular shape in the bone 112. Further,upon attaining a particular depth or shape in the bone 112, the bonepreparation device 102 can be removed from the connection member 214 andreplaced with a different sized bone preparation device 102, such as alarger broach, and the process can be repeated until a particular sizeand/or shape is attained in the bone 112.

While the above example of the forming tool 100 was discussed in termsof use with a bone preparation device 102, a variety of other componentscan be attached to the forming tool 100 in a similar manner, including,but not limited to, trial components for the implant device.Additionally, according to certain embodiments, the bone preparationdevice 102 can be indirectly connected to the connection member 214. Forexample, the connection member 214 can be connected to a first end of anextension or coupling in a similar manner as discussed above withrespect to the bone preparation device 102, with the bone preparationdevice 102 being attached to a second end of the extension or coupling.Additionally, according to certain embodiments, the proximal end 106 ofthe forming tool 100 is structured for coupling to another instrumentthat can assist in the formation of the augment opening 114, including,for example, an oscillating saw or drill.

Referencing FIGS. 7A-7C, during use, the position of the guide 108, andthus the longitudinal guide axis 110, within the guide slot 136 canprovide a reference axis for positioning the central cutting axis 238and/or the central augment axis 116, which can be at the same location,for forming the augment opening 114 in a bone via use of the formingtool 100. As shown in FIG. 7A, in certain instances, the guide 108 canbe positioned within the guide slot 136 so that the longitudinal guideaxis 110 is generally positioned along the forming axis 240 of theforming tool 100. Moreover, in such a situation, the longitudinal guideaxis 110 can be positioned within the guide slot 136 at a position inwhich the augment opening 114 formed by use of the forming tool 100 isgenerally aligned with, or not offset from, the longitudinal guide axis110. Further, as previously mentioned, the longitudinal guide axis 110can correspond to, among other axes, the central axis of anintramedullary canal which may, or may not, have previously been shapedfor receipt of a stem of an implant device. However, according to othersituations, the forming tool 100 can be positioned relative to the guide108 such that the guide 108 that extends into the guide slot 136 isoffset from the forming axis 240. For example, as shown in FIG. 7B, atleast the guide slot 136 can be structured so that the guide 108 can belinearly offset from the longitudinal sleeve axis 130, which can beshared by the forming axis 240, such that the forming tool 100 will forman augment opening 114 having a central augment axis 116 that islinearly offset to the left (as indicated by “O₁” in FIG. 7B) of atleast the longitudinal guide axis 110. Similarly, as shown in FIG. 7C,during other uses, at least the guide slot 136 can be structured so thatthe guide 108 can be linearly offset from the longitudinal sleeve axis130, and thus the forming axis 240, such that the forming tool 100 willform an augment opening 114 having a central augment axis that isliterally offset to the right (as indicated by “O₂” in FIG. 7C) of atleast the longitudinal guide axis 110. In the examples provided by FIGS.7A-7C, the angular position of the longitudinal guide axis 110 relativeto at least the longitudinal sleeve axis 130 and/or the forming axis 240remains the same, as indicated, for example, by the indicator 148 of theselector body 124 remaining at the “6” position. However, as previouslydiscussed, in additional to be linearly offset, as shown in FIGS. 7B and7C, the angular orientation of the position of at least the longitudinalsleeve axis 130 and/or the forming axis 240 relative to the longitudinalguide axis 110 can be adjusted by adjusting the orientation of theselector body 124, and thus the guide slot 136, relative to at least theselector hub 158.

As previously discussed, FIGS. 8A-8C provide another embodiment of theforming tool 100 in which the guide slots 136′ of the sleeve member 118are pre-set to provide a particular linear offset distance between atleast the guide slot axis 138 and the longitudinal axis 130, which inthe illustrated embodiment can be positioned along, or shared by, theforming axis 240 and the handle axis 194. Additionally, relative to thesettings of the guide slots 136′ of the embodiment depicted in FIGS.7A-7C, the examples provided by FIGS. 8A-8 c also demonstrate the guideslot axes 138 being angularly offset from at least the longitudinalsleeve axis 130. For example, not only are the guide slot axes 138 inFIGS. 8A-8C positioned at linear offset distances of D₁, D₂, and D₃, theguide slot axis 138 are also angularly offset so that, in reference toFIGS. 8A-8C, the guide slot axis 138 are above and to the right of thelongitudinal guide axis 110. In the illustrated examples, such angulardisplacement is attained by setting the indicator 148 of the selectorbody 124 to the “8” position relative to the selector hub 158, andthereby adjusting the angular location of the guide slot axis 138relative to the longitudinal sleeve axis 130 and/or the forming axis240.

FIG. 19 illustrates a front view of an exemplary tibial implant 246having a tibial tray 248, a tibial augment 250, and a stem 252. Avariety of different augments can be used for the tibial augment 250,including, for example, a cone or sleeve augment, among other augments.As shown, according to illustrated example, the tibial tray 248 caninclude a central tray axis 258 that is offset from a central augmentaxis 116 of the tibial augment 250. Similarly, the stem 252 can extendalong a stem axis 256 that is offset from the central augment axis 116and the tray axis 258, the stem axis 256 and the tray axis 258 being onopposing sides of the central augment axis 116.

FIGS. 20A-20C illustrate examples of use of a forming tool 100 having anelongated guide slot 136 similar to that depicted in FIGS. 5 and 7A-7Cto alter the location of the central augment axis 116, and thus thelocation of the tibial augment 250, in the bone 112, relative to atleast the stem 252 and/or the tibial tray 248. In the illustratedembodiment, adjustments in the positioning of the forming tool 100 thatare provided by the size of the guide slot 136, such as the linearlength of the guide slot 136 (as indicated by “L” in FIG. 9), canfacilitate the location of the formed central augment axis 116 relativeto either, or both, of the longitudinal stem axis 256 and tray axis 258.Moreover, such adjustment of the location of the central augment axis116 can impact the location of the associated tibial augment 250 and thestem 252 and/or tibial tray 248. For example, as shown in FIG. 20A, theforming tool 100 can be oriented to position the central augment axis116 at a generally central location between the longitudinal stem axis256 and tray axis 258. However, the elongated configuration of the guideslot 136 can provide the ability to linearly displace the position ofthe forming tool 100 in a first direction so as to decrease the distancebetween the central augment axis 116 and the stem axis 256, or increasethe distance between the central augment axis 116 and the tray axis 258,as shown, for example, in FIG. 20B. Further, according to certainembodiments, the guide slot 136 can have a length that allows thecentral augment axis 116 to be positioned at a location where a portionof the tibial tray 248, such as, for example, a tray stem 254, cancontact the tibial augment 250 at a first contact location 260.Similarly, the elongated configuration of the guide slot 136 can providethe ability to linearly displace the position of the forming tool 100 ina second direction so as to decrease the distance between the centralaugment axis 116 and tibial tray axis 258, or increase the distancebetween the central augment axis 116 and the stem axis 256, as shown,for example, in FIG. 20C. Further, according to certain embodiments, theguide slot 136 can have a length that allows the central augment axis116 to be positioned at a location where a portion of the stem 252 cancontact the tibial augment 250 at a second contact location 262.

FIGS. 21A-C also illustrate use of the forming tool 100 to adjust thelocation of the central augment axis 116 relative to the tray axis 258and stem axis 256, but via use three sleeve members that are similar tothe sleeve members 118 and guide slots 136′ shown in FIGS. 6 and 8A-8C.Moreover, the linear offset distance provided by each of the guide slots136′ illustrated in FIGS. 21A-C differ and/or the angular orientation isaltered so as to vary the linear distance between the central augmentaxis 116 and the stem axis 256 and tibial tray axis. For example, FIG.21A illustrates use of a sleeve member 118 having a guide slot 136′ thathas a linear offset distance that is less than that shown for the guideslot 136′ associated with FIG. 21B. Accordingly, compared to the guideslot 136 used in FIG. 21A, the guide slot 136′ associated with FIG. 21Bhas a linear offset distance such that, when used with the same angularorientation, brings the central augment axis 116 into closer proximityto the tibial tray axis 258, and increases the distance between thecentral augment axis 116 and the stem axis 256. Similar to FIG. 20C, theoffset provided by the positioning of the guide slot 136′ can allow thecentral augment axis 116 to be positioned at a location where a portionof the stem 252 can contact the tibial augment 250 at a second contactlocation 262. FIG. 21C illustrates use of a sleeve member 118 having aguide slot 136′ that provides the same or similar offset as provided bythe guide slot 136′ shown in FIG. 21B, but with the angular position ofthe guide slot rotated approximately 180 degrees. Moreover, referencingFIGS. 8A-8C, the alignment of the central augment axis 116 relative tothe stem axis 256 and/or tibial tray axis 258 shown in FIG. 21B may havebeen attained by aligning the indicator 148 of the sleeve member 118 atthe “6” position, while of the alignment central augment axis 116 shownin FIG. 21C may have been attained by aligning the indicator 148 of thesame sleeve member 118 in the “12” position. Thus, in this example, byaltering the angular position of guide slot, compared to FIGS. 21A and21B, the central augment axis 116 is extended further from the tibialtray axis 258, and the distance between the central augment axis 116 andthe stem axis 256 is decreased. Further the guide slot 136′ shown inFIG. 21C can, similar to FIG. 20B, provide a linear offset distance thatallows the central augment axis 116 to be positioned at a location wherea portion of the tibial tray 248, such as, for example, a tray stem 254,can contact the tibial augment 250 at the first contact location 260.

While the invention has been described in connection with what ispresently considered to be the most practical and preferred embodiment,it is to be understood that the invention is not to be limited to thedisclosed embodiment(s), but on the contrary, is intended to covervarious modifications and equivalent arrangements included within thespirit and scope of the appended claims, which scope is to be accordedthe broadest interpretation so as to encompass all such modificationsand equivalent structures as permitted under the law. Furthermore itshould be understood that while the use of the word preferable,preferably, or preferred in the description above indicates that featureso described can be more desirable, it nonetheless may not be necessaryand any embodiment lacking the same may be contemplated as within thescope of the invention, that scope being defined by the claims thatfollow. In reading the claims it is intended that when words such as“a,” “an,” “at least one” and “at least a portion” are used, there is nointention to limit the claim to only one item unless specifically statedto the contrary in the claim. Further, when the language “at least aportion” and/or “a portion” is used the item may include a portionand/or the entire item unless specifically stated to the contrary.

The invention claimed is:
 1. An apparatus for use with a bone preparation device, the apparatus comprising: a sleeve member having a guide slot sized to receive axial passage of at least a portion of a guide, the guide slot sized to accommodate linear displacement of the sleeve member about the guide in one or more directions perpendicular to a longitudinal guide axis of the guide; a handle member having an inner area sized to receive insertion of at least a portion of the sleeve member, the handle member having a connection member structured to be coupled to the bone preparation device; and a retention member adapted to selectively secure the sleeve member to the handle member at a selected one of a plurality of rotational positions, each of the plurality of rotational positions adjusting an angular position of at least the sleeve member relative to the handle member; and wherein the connection member comprises a first arm and a second arm, the first and second arms extending from a distal end of the handle member, the first and second arms adapted to securely engage the bone preparation device.
 2. The apparatus of claim 1, wherein the connection member includes an adjustable slide that is coupled to the first and second arms, the first and second arms adapted to be axially displaced by axial displacement of the adjustable slide along at least a portion of the handle member.
 3. The apparatus of claim 2, wherein the adjustable slide is adapted for rotational displacement about at least a portion of the handle member, and wherein the first and second arms each include a base portion and an arm extension, the arm extension being generally perpendicular to the base portion and structured to be received in an undercut of the bone preparation device.
 4. An apparatus for use with a bone preparation device, the apparatus comprising: a sleeve member having a guide slot sized to receive axial passage of at least a portion of a guide, the guide slot having a central guide slot axis that is offset from a longitudinal sleeve axis of the sleeve member; a handle member having an inner area sized to receive removable insertion of at least a portion of the sleeve member, the handle member having a connection member structured to be coupled to the bone preparation device; and a retention member adapted to selectively secure the sleeve member to the handle member at a selected one of a plurality of rotational positions, each of the plurality of rotational positions adjusting an angular position of at least the guide slot relative to a longitudinal handle axis of the handle member; and wherein the connection member comprises a first arm and a second arm, the first and second arms extending from a distal end of the handle member, the first and second arms adapted to securely engage the bone preparation device.
 5. The apparatus of claim 4, wherein the connection member includes an adjustable slide that is coupled to the first and second arms, the first and second arms adapted to be axially displaced by axial displacement of the adjustable slide along at least a portion of the handle member.
 6. The apparatus of claim 5, wherein the adjustable slide is adapted for rotational displacement about at least a portion of the handle member, and wherein the first and second arms each include a base portion and an arm extension, the arm extension being generally perpendicular to the base portion and structured to be received in an undercut of the bone preparation device. 